Fosaprepitant
- Product NDC
- 0338-0008
- 11-digit product format
- 003380008
- Labeler code
- 0338
- Product ID
- 0338-0008_67f5816c-3188-40f9-9a8f-97e92a26ff73
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fosaprepitant Dimeglumine
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Baxter Healthcare Corporation
- Application
- ANDA211860
- Marketing category
- ANDA
- Marketing start
- 2019-09-05
- Substance
- FOSAPREPITANT DIMEGLUMINE
- Active strength
- 150 mg/5mL
- Pharmacologic classes
- Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Neurokinin 1 Antagonists [MoA], Substance P/Neurokinin-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fosaprepitant
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FOSAPREPITANT DIMEGLUMINE | 150 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | D35FM8T64X |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0338-0008-01 | Fosaprepitant | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 5 | | 8 |
| 0338-0008-01 | Fosaprepitant | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0338-0008 | FOSAPREPITANT (FOSAPREPITANT DIMEGLUMINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BAXTER HEALTHCARE CORPORATION] | 7 | Current NDC, Legacy NDC, 2 package rows | 20250228_3ed3e0a9-a0a8-4555-9f73-2043e79e3398.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0338-0008-01 | 00338000801 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0338-0008-01) / 5 mL in 1 VIAL, SINGLE-DOSE | 2019-09-05 | 0000-00-00 | No | No | Current |